Overview
Central Integrated Scientific Review Committee Lead – Global Pharmaceutical Company
Contract: 12 - 18 months
Location: London (Hybrid)
SRG are working with a Global Pharmaceutical company to help them find a Central Integrated Scientific Review Committee Lead to join their busy team.
The Central Integrated Scientific Review Committee Lead (C-ISRC Lead) plays a key role in the review and approval of clinical documents across therapeutic areas in Development. Key to the role is following documents from C-ISRC submission to finalization, including meeting preparation, meeting management and documentation via minutes for completeness, consistency and process adherence. In collaboration with the C-ISRC Chair and Co-Chair (Clinical Development Head) you will act as project manager in the review cycle and associated activities for high-quality and efficient C-ISRC meeting. Key outcomes are high-quality concept sheets, protocols and clinical development plans.
Responsibilities
* Manages C-ISRC Review process for approximately 100+ clinical documents each year
* Ensures appropriate C-ISRC documentation and meeting management
* Assists in the development of high-quality protocols and other clinical documents by addressing C-ISRC processes/workflow related questions
* Provides training and guidance as appropriate
* Works with various systems and trackers to ensure smooth C-ISRC workflow (e.g., CAT, Please Review, Document Management System)
* May work on system improvement as appropriate
* Serves as back-up to fellow C-ISRC Leads and may attend C-ISRC meetings to take minutes or co-facilitate the sessions
* Manages timely key data entry to create reports from appropriate systems and facilitates tracking of key metrics for the C-ISRC Office
* May assist in audits and inspection readiness related to C-ISRC processes and documentation
* Supports other C-ISRC and Clinical Development projects and activities as appropriate (e.g., updating guidance, contributing to trainings and best practices)
Candidate Requirements
* Minimum Bachelor’s degree in science; Advanced degree, or equivalent, in science or healthcare preferred.
* 5+ years’ experience in pharmaceutical industry
* Strong knowledge of clinical drug development process, including trial design, GCP, regulatory processes, and clinical project management
* Working knowledge of IT systems and trackers, including Document Management System
* Excellent interpersonal, communication, presentation and meeting management skills
* Advanced medical/scientific writing and communication skills
* Ability to influence wide variety of stakeholders in a matrix environment
Seniority level
* Director
Employment type
* Contract
Job function
* Project Management
* Industries: Pharmaceutical Manufacturing
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